carboplatin and paclitaxel albumin-stabilized nanoparticle formulation in treating patients with advanced or metastatic solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving paclitaxel albumin-stabilized nanoparticle formulation together with carboplatin may kill more tumor cells. purpose: this phase i trial is studying the side effects, the best way to give, and the best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with carboplatin in treating patients with advanced or metastatic solid tumors.

objectives: primary * determine the maximum tolerated dose (mtd) of paclitaxel albumin-stabilized nanoparticle formulation given once weekly for 3 weeks when administered with carboplatin given once every 4 weeks. * determine the mtd of paclitaxel albumin-stabilized nanoparticle formulation given once every 3 weeks when administered with carboplatin given once every 3 weeks. * determine the mtd of paclitaxel albumin-stabilized nanoparticle formulation given in weeks 1 and 2 when administered with carboplatin given once every 3 weeks. * evaluate sequence-dependent effects on toxicity and pharmacokinetics in the combination of paclitaxel albumin-stabilized nanoparticle formulation and carboplatin. secondary * explore the antitumor activity of paclitaxel albumin-stabilized nanoparticle formulation given once weekly or once every 3 weeks. outline: patients are assigned to 1 of 3 treatment arms. * arm i: patients receive carboplatin iv over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation iv over 30 minutes on days 1, 8, and 15. treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. * arm ii: patients receive carboplatin iv over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation iv over 30 minutes on day 1. treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. * arm iii: patients receive carboplatin iv over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation iv over 30 minutes on days 1 and 8. treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. patients in arms i and ii undergo blood sample collection periodically for pharmacokinetic studies. after completion of study treatment, patients are followed at 30 days.

Eligibility criteria:
disease characteristics: inclusion criteria: * histologically or cytologically confirmed solid tumor * advanced or metastatic disease * measurable or evaluable disease * must meet 1 of the following criteria: * failed a standard therapy * not a candidate for standard therapy * have a disease for which there is no defined standard therapy exclusion criteria: * symptomatic brain metastases patient characteristics: inclusion criteria: * ecog performance status 0-2 * life expectancy ≥ 8 weeks * absolute neutrophil count \> 1,500/mm\^3 * platelet count \> 100,000/mm\^3 * hemoglobin \> 8.0 g/dl * total bilirubin normal * serum creatinine normal or creatinine clearance ≥ 60 ml/min * ast and alt ≤ 2.5 x upper limit of normal * negative pregnancy test exclusion criteria: * pregnant or lactating * prior anaphylactic reaction or severe allergic reaction to paclitaxel and/or docetaxel * active infection that requires treatment with antibiotics for \> 4 weeks * uncontrolled congestive heart failure * symptomatic coronary artery disease or heart block * myocardial infarction within the past 3 months * peripheral neuropathy ≥ grade 2 from any cause prior concurrent therapy: * no prior chemotherapy, radiotherapy, or any other therapy for malignancy within the past 3 weeks * no concurrent filgrastim, pegfilgrastim, or sargramostim during the first course of therapy

Keywords: unspecified adult solid tumor, protocol specific